[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Notices]
[Page 51464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22183]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3343]
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory
Committee, Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the
Dermatologic and Ophthalmic Drugs Advisory Committee for an additional
2 years beyond the charter expiration date. The new charter will be in
effect until October 7, 2020.
DATES: Authority for the Dermatologic and Ophthalmic Drugs Advisory
Committee will expire on October 7, 2018, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, email: [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee
(the Committee). The Committee is a discretionary Federal advisory
committee established to provide advice to the Commissioner.
The Committee advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which FDA
has regulatory responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of dermatologic and ophthalmic
disorders and makes appropriate recommendations to the Commissioner.
The Committee shall consist of a core of nine voting members
including two Chairpersons. Members and the Chairpersons are selected
by the Commissioner or designee from among authorities knowledgeable in
the fields of dermatology, ophthalmology, internal medicine, pathology,
immunology, epidemiology or statistics, and other related professions.
Members will be invited to serve for overlapping terms of up to 4
years. Almost all non-Federal members of this committee serve as
Special Government Employees. The core of voting members may include
one technically qualified member, selected by the Commissioner or
designee, who is identified with consumer interests and is recommended
by either a consortium of consumer-oriented organizations or other
interested persons. In addition to the voting members, the Committee
may include one non-voting member who is identified with industry
interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/ucm094782.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT).
In light of the fact that no change has been made to the committee
name or description of duties, no amendment will be made to 21 CFR
14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22183 Filed 10-10-18; 8:45 am]
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